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3 reasons to engage patients in clinical-trial protocol design and planning

Understanding and incorporating patients’ experiences in the clinical-trial planning process helps ensure the success of trials for both patients and the industry alike.

It’s crucial to gather and incorporate patient feedback into the design and planning of clinical trials, not only for the success of those trials, but also for the positive impact it has on both patients and the industry as a whole. Engaging patients early in the clinical-trial design process helps industry leaders ensure that the trials they plan will adequately meet the needs of their participants, thus increasing their involvement in the trials themselves.    

Fortunately for clinical researchers, there are many ways to get patients involved in the trial-planning process, such as reaching them through advocacy organizations or engagement organizations focused on surveying patients for their feedback and experience data, says Ella Balasa, a patient advocate and consultant. Below, she shares three reasons why understanding patients’ preferences and incorporating their experiences into clinical-trial design and planning can help improve trial success rates for both patients and the industry.  

1. Applying a patient-centric approach to trial designs helps ensure optimal resulting treatments  

A clear understanding of patients’ symptoms and experiences can help manufacturers create treatments that more effectively align with patients’ needs. By powering trials for endpoints based on those needs, investigators can better test whether a treatment will be beneficial.    

And, after a drug has been approved, “Patients are then more likely to potentially use it, since they know that other patients were involved in the process, and that the product will then be most suited for them,” Balasa explains.   

But to be truly patient-centric, trial planners must go beyond merely asking patients for their feedback and take it a step further. “Being patient-centric can’t just be a box-checking exercise,” Balasa says. “Patient input must be holistically considered and then implemented when and where possible.”    

Diversity is another important factor to consider when engaging patients in the clinical-trial planning process. By ensuring that feedback is gathered from a range of patients with varying disease experiences, investigators can more fully take into account different types of patients and their diverse backgrounds—which ultimately expands trial planners’ knowledge about the safety and efficacy of potential new treatments.    

2. Early engagement with patients increases their likelihood of participating in clinical trials    

Understanding the factors that affect patients’ ability and willingness to participate in clinical trials and structuring them to meet their needs may increase trial participation, which, in turn, can help speed up the regulatory approval process.   

Having access early on to more insights—such as patients’ top priorities for treatments—helps limit the chances of investigators needing to go back and alter protocol after the development stage. The resulting savings in time and financial resources can be reallocated into improving the accuracy of early research results and, in turn, help to accelerate the FDA approval process.    

Plus, when asked directly to be involved in the clinical trial development and design process, patients not only feel inclined to do so for their own early access to treatments but other patients, too, feel empowered to participate having learned through patient organizations, forums and brand marketing that the end product was developed with actual patient experiences incorporated so early on.  

“Patients can help with shaping the direction of research questions and determining what is most important to other future trial participants,” Balasa says.   

3. Gathering patient feedback improves trust between patients and brands    

Both patients and life sciences organizations have the same goal: They want to improve health outcomes. Incorporating patient feedback into clinical-trial design and planning can help strengthen the relationship between patients and manufacturers by showing patients that their needs are being addressed and helping them take a more active role in their treatment opportunities.    

“When patients aren’t involved in the development process, they can feel like they’re merely a participant in the trial or just a receiver of the drug,” Balasa says. “By incorporating their feedback into the design process, patients feel empowered and [they] know they’re going to be receiving a treatment that is optimized to their disease.”    

And reaching patients through channels they trust can not only help increase the number of survey participants and overall feedback available on design and trial planning, but also help foster greater trust in life sciences organizations among patients who are interested in learning more about relevant clinical trial opportunities. A recent Phreesia survey of more than 4,300 patients found that patients trust digital appointment check-in more than any other media platform for clinical-trial information.